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Nipro RO medical Operator's Manual

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Operator´s Manual
RO MEDICAL
Description: NRO-MED-IFU-1001
Date: 06.10.2021
|
Version: 12
Written by: Nipro Pure Water

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Summary of Contents for Nipro RO medical

  • Page 1 Operator´s Manual RO MEDICAL Description: NRO-MED-IFU-1001 Date: 06.10.2021 Version: 12 Written by: Nipro Pure Water...

  • Page 3: Table Of Contents

    Version 12| 06.10.2021 Page 3 Table of Contents General ....................6 Scope of supply ................... 6 Unit combinations ................6 Notes for the Operator................6 Laws and Standards ................6 Symbols used in this Manual ..............7 Transport and Storage ................7 Model Plate ..................
  • Page 4 Version 12| 06.10.2021 Page 4 Device on / off with permeate tank ............23 Emergency operation ................24 Operating displays ................25 Error messages / troubleshooting ............26 Error messages .................. 26 Clear alarms..................26 Maintenance and cleaning ..............27 External Cleaning ................
  • Page 5 Version 12| 06.10.2021 Page 5 For the reverse osmosis type RO medical, conformity according to 0297 EC directives is declared Foreword This Operator’s Manual includes all information required for the installation and operation for the reverse osmosis model RO medical.

  • Page 6: General

    Version 12| 06.10.2021 Page 6 1 General 1.1 Scope of supply The scope of delivery includes the following parts:  1 reverse osmosis  1 connection set 1.2 Unit combinations The unit model RO may be combined with the following devices: ...

  • Page 7: Symbols Used In This Manual

    Version 12| 06.10.2021 Page 7 1.5 Symbols used in this Manual Stands for a dangerous situation. Disregard can result in personal injury or material damage. Stands for information and valuable tips. 1.6 Transport and Storage Protect unit against frost and moisture Protect against strong jolting and collisions.

  • Page 8: Model Plate

    1.8 Warning on the Unit. Caution voltage. Turn mains switch off before opening housing. Fixed on control cabinet. 1.9 Shutdown If a unit is shutdown for more than 5 days, conservation will be necessary. Please contact Nipro Pure Water before performing conservation.

  • Page 9: Disposal

    Version 12| 06.10.2021 Page 9 1.10 Disposal Regarding the WEEE guidelines of the European Union, the disposal of electronic devices and electronic sub-assemblies and parts into the general garbage is not lawful. These parts must be disposed environmentally appropriate: If not appointed otherwise and no private disposal management is available, these devices or possibly other environmental hazardous items can be sent back.

  • Page 10: Intended Operation

    The device has pressurized parts. If the temperature sensor fails, the temperature in the permeate can increase. (Max 60°C) The water treatment system RO medical may only be used for permeate supply of dialysis devices, which have a temperature measurement (permeate temperature).

  • Page 11: Contraindications / Side Effects

    2.1 Contraindications / side effects None 3 Safety 3.1 Risk Assessment There will be no dangers associated with the reverse osmosis model RO medical D if the operating instructions are followed. The device can automatically start by way of an auto-start. 3.2 EMC The device was developed and tested in accordance with current standards.

  • Page 12: Technical Data

    9,9 A x 60 Hz Degree of pollution Ambient temperature Storage / transport 3-40°C Operation 10-35°C Air pressure 795-1062 hPa Display system Conductivity 0-1000 µS/cm ±5% pressure switch 0-10 bar ±5% Flow (sight glass) 300-3000 l/h ±5% 100-1000 l/h Size RO Medical 1000x500x1640...

  • Page 13: Description Of The Device

    Version 12| 06.10.2021 Page 13 5 Description of the device 5.1 Flow-Chart 1. Magnetic valve inlet 9. Temperature sensor 2. Pressure switch input 10. Conductivity probe permeate flow 3. Disinfection point 11. Permeate pressure switch 4. Conductivity input 12. Connection back flow hose nozzle d20 5.

  • Page 14: Functional Sequence

    The permeate content flows through the flow indicator (7), the temperature sensor (8), the conductivity probe (9) and the pressure switch (10) into the ring line. The unused permeate flows back into the RO medical via the connection (12).

  • Page 15: Safety Devices / Components

    Version 12| 06.10.2021 Page 15 5.3 Safety devices / Components Pressure tube with Display membrane Turn on key Pressure switch Permeat Flow Main switch Connection Pressure Switch Inlet Emergency Service Point Mode switch Flow Display Concentrate Fault signal lamp Flow Display Permeat Manometer Pump pressure...

  • Page 16: Installation

    Version 12| 06.10.2021 Page 16 6 Installation The installation must be conducted by the manufacturer or by personnel trained and authorized by the manufacturer. 6.1 Environmental Condition Conditions for the osmosis room:  Relative air moisture < 90% at 20°C ...

  • Page 17: Electrical Installation

    The disconnection via the main switch at the control cabinet. The power cord must be provided with a strain relief. Connection cable RO Medical For protection against a re-start of the unit, the main switch can be locked with a padlock.

  • Page 18: Prefiltration (Example)

    6.4 Prefiltration (Example) Install the necessary water pre-treatment equipment first! Only then connect the RO medical and start up Local water works regulations and DIN EN 1717 must be followed. The water pre-treatment must be adapted to the local potable water quality.

  • Page 19: Commissioning

    Version 12| 06.10.2021 Page 19 6.5 Commissioning Caution, device damage! The device must be preconnected by a suitable pre-filter and a softening system as well as a pressure reducer. Permeat Flow Connection (2) Hose nozzle d20 Drain water connection (4) Permeat back flow (3) HT 40 Hose nozzle d20...

  • Page 20: Initial Commissioning

    Version 12| 06.10.2021 Page 20 6.6 Initial commissioning Connect and check the raw water connection (1), permeate flow (2), permeate back flow (3) and waste water (4) Open the inlet valve manually. To do this, turn the white magnet coil 45° counter clockwise. Now water is running into the device.

  • Page 21: Operation

    Version 12| 06.10.2021 Page 21 7 Operation 7.1 Control Panel Display (3) Right Side Main Switch (5) Toggle switch (1) Key switch emergency Fault light (2) operation (4) 1. Toggle switch system on 4. Key switch emergency operation This is used to switch the device on The device can be switched to and off emergency operation here.

  • Page 22: System On / Off Without Permeate Tank

    Version 12| 06.10.2021 Page 22 2. Fault light Lights up when there is a fault 3. Display 5. Main switch Display of conductivity and faults With this the device can be switched off completely 7.2 System on / off without permeate tank System on To start the device, turn the toggle switch to the right (on position).

  • Page 23: Device On / Off With Permeate Tank

    Page 23 7.3 Device on / off with permeate tank If the RO medical is connected to a permeate tank, the toggle switch must be set to "Auto". Since the device switches off automatically when the tank is full, it is not necessary to reset it to position 0.

  • Page 24: Emergency Operation

    Version 12| 06.10.2021 Page 24 7.4 Emergency operation Caution! If the HC Medical hot cleaning system is connected, the following steps must be carried out before emergency operation: 1. Check HC Medical for pending alarms. 2. Carefully touch the lines of the HC Medical and check whether they are warm.

  • Page 25: Operating Displays

    Version 12| 06.10.2021 Page 25 7.5 Operating displays Device is off. System Off Rinsing interval (target) is set to 90 minutes. Set: 90:00 25:22 min have already passed. Actual: 25:22 If the actual value reaches the set point, the system goes into rinsing. Until rinsing Device is on.

  • Page 26: Error Messages / Troubleshooting

    Version 12| 06.10.2021 Page 26 8 Error messages / troubleshooting 8.1 Error messages Display Error Description Troubleshooting The motor protection switch of the pump has Turn the motor protection Error triggered. Check motor protection switch. If switch back to position 1. Motor protection triggered this alarm occurs frequently, the pump must Check 1Q5...

  • Page 27: Maintenance And Cleaning

    Version 12| 06.10.2021 Page 27 9 Maintenance and cleaning 9.1 External Cleaning Stains and dust can be removed with a cloth and a commercially available cleaner. Do not clean the device with solvents. Stains from softening salts or disinfectants must be removed immediately.

  • Page 28: Maintenance Intervals

    Version 12| 06.10.2021 Page 28 9.2 Maintenance Intervals Measure period Notes user Fill salt at softener Daily user Chemical disinfection If needed Manufacturer or persons authorized by manufacturer Maintenance Yearly Manufacturer or persons authorized by manufacturer Safety related check Every 2 years Manufacturer or persons authorized by manufacturer...

  • Page 29: Chemical Disinfection

    9.3 Chemical Disinfection A chemical disinfection should only be performed upon new installation or when high pathogen values are encountered Disinfection may only be performed by Nipro Pure Water or by instructed persons. Caution when handling disinfectants! Per acetic acids can cause damage to your health. Always read safety guidelines before handling.

  • Page 30: Microbiological Inspection

    Version 12| 06.10.2021 Page 30 9.4 Microbiological Inspection Necessary Values Pathogens < 100 CFU/ml no traces of Pseud. aeruginosa and E. coli Endotoxins < 0,25 EU/ml Inspection Interval Inspection of permeate every 3 months. Inspection method Pathogen count determination: Nutrient medium: TGEA (OXID Nr.CM 127), R2A Incubation temperature: 22°C ±...

  • Page 31: Display / Parameter

    Version 12| 06.10.2021 Page 31 Display / Parameter 10.1 Retrieval of the operating hours / conductivities Press the F1 key. The operating hours are displayed. If the key is pressed again, the display changes back to the standard display. The X indicates which key can be used to switch back to the standard display.

  • Page 32: Change The Conductivity Parameter

    Version 12| 06.10.2021 Page 32 10.2 Change the conductivity parameter Press the F4 key and F2 key simultaneously. The conductivity in the return is displayed. Press the ESC key for 3 seconds, the first value is marked. Press enter Set the value with the arrow keys (up / down). Complete the entry with ENTER.

  • Page 33: Change Parameter Temperature

    Version 12| 06.10.2021 Page 33 10.3 Change parameter temperature Press the F4 key and F3 key simultaneously. The temperature is displayed. Press the ESC key for 3 seconds, the first value is marked. Select corresponding value with the arrow keys. Press enter Set the value with the arrow keys (up / down).

  • Page 34: Technical Appendix

    Version 12| 06.10.2021 Page 34 Technical appendix The settings and functions described below may only be carried out by technically trained personnel. ATTENTION. DANGER TO PERSONS AND SYSTEM TECHNOLOGY! Incorrect settings can lead to hazards No service or maintenance work may be carried out during treatment.

  • Page 35: Replacement Of The Reverse Osmosis Membrane

    Version 12| 06.10.2021 Page 35 Replacement of the reverse osmosis membrane Caution pressure! Membrane tubes are under pressure. Please open carefully. The settings and functions described below may only be carried out by technically trained personnel. Switch off the system at the main switch. Open wing screw and take off the clip Lift module cover by using a screwdriver.

  • Page 36: Service Parameters

    Version 12| 06.10.2021 Page 36 Rinse membrane! After the new membrane has been installed the mode “drain permeate” has to be started for 20 minutes. Service Parameters The settings and functions described below may only be carried out by technically trained personnel.

  • Page 37: Adjustment Of The Conductivity

    Version 12| 06.10.2021 Page 37 12.1 Adjustment of the conductivity - Call up parameters B21, B36 or B37. - "Ax" value = displayed conductivity - Select value "B" and confirm with Enter. - Change the value with the arrow keys. (+00001 = current value +1) - press enter - Press ESC several times (until time is displayed), then arrow key up.

  • Page 38: Auto Start (Timer)

    Version 12| 06.10.2021 Page 38 12.4 Auto Start (Timer) Call up service mode Logo settings < ENTER > Program < ENTER > Set parameters < ENTER > Select parameter B040<ENTER> To set the on-/off-times: -Move the cursor to one of the parameters of the timer. -Press ENTER.

  • Page 39: Service Point

    Version 12| 06.10.2021 Page 39 12.5 Service point The service point can be used for water withdrawal to check water temperature and conductivity. Service point may only be opened, if operating pressure in the system is reached. Service point must be closed prior to each system start. Service point may only be operated by technically trained personnel.

  • Page 40: Disinfection

    Version 12| 06.10.2021 Page 40 Disinfection Disinfection may only be performed by Nipro Pure Water or by instructed persons. Caution when handling disinfectants! Per acetic acids can cause damage to your health. Always read safety guidelines before handling. To be performed precisely! Danger Ensure that no dialysis can be performed while disinfecting.
  • Page 41 Version 12| 06.10.2021 Page 41 Connect the disinfection pump to the disinfection point. Open the three-way valve permeate to the drain. Start the device Start the disinfectant pump. Check for correct disinfectant concentration at the permeate outlet with test strips. Use Minncare Test Strips Indication 1% for this.
  • Page 42 Version 12| 06.10.2021 Page 42 Open the three-way valve permeate to the drain. Let the system run until no more disinfectant can be detected at the permeate drain. Use Minncare residual test strips for this. Close the three-way valve permeate to the drain. Check that all dialysis stations are free from disinfectants.

  • Page 43: Disinfection Protocol

    Dialysis centre Section Contact person Function Street / Bldg. No. Postcode / City Unit model : RO Medical Serial number: Ring line length Disinfectant type Inoculated amount in litres Wash time in minutes Wait time in minutes Tested for disinfectant at all dialysis...

  • Page 44: Emc Manufacturer's Declaration

    Version 12| 06.10.2021 Page 44 EMC manufacturer's declaration Electromagnetic emissions and electromagnetic immunity The RO device is intended for use in electromagnetic environments as described below. The customer or the operator of the RO should ensure that the device is only used in such an environment.
  • Page 45 Version 12| 06.10.2021 Page 45 Test level – IEC Compliance Electromagnetic Immunity test 60601 level environment - Guidelines Discharge of ± 6 kV contact ± 6 kV contact The floor should be made of static electricity discharge discharge wood, concrete, or of tiles. In (ESD) in ±...
  • Page 46 Version 12| 06.10.2021 Page 46 d = 2.3 P 800 MHz to 2.5 Whereby P is the maximum nominal output of the respective transmitter specified by the manufacturer in Watts (W), and d is the recommended safety distance in meters (m). The field strength of stationary RF transmitters, which is definable via...
  • Page 47 Version 12| 06.10.2021 Page 47 Recommended minimum distances between portable and mobile RF communication devices and the RO The RO is intended for use in electromagnetic environments in which radiated RF disturbances are controlled. The buyer or user of the RO can help prevent electromagnetic interference by maintaining a minimum distance between portable/mobile RF communications equipment (transmitters) and the RO as recommended below, according to the maximum output power of the communications equipment Max.

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